U.S. patent application number 17/618989 was filed with the patent office on 2022-09-29 for endoscope storage tray having apertures and method of use.
The applicant listed for this patent is Medivators Inc.. Invention is credited to Mark Jackson, Stephen Nichols, Colin Oxford, Gary Spencer.
Application Number | 20220304762 17/618989 |
Document ID | / |
Family ID | 1000006459124 |
Filed Date | 2022-09-29 |
United States Patent
Application |
20220304762 |
Kind Code |
A1 |
Jackson; Mark ; et
al. |
September 29, 2022 |
ENDOSCOPE STORAGE TRAY HAVING APERTURES AND METHOD OF USE
Abstract
An endoscope tray is provided. The tray comprises an interior
for storage of an endoscope. The interior has an upstanding element
having a top surface, and a plurality of apertures disposed on at
least a portion of the top surface of the upstanding element to
facilitate drainage of fluids. Systems and methods are also
provided.
Inventors: |
Jackson; Mark; (Great
Wakering, GB) ; Spencer; Gary; (Rayleigh, GB)
; Oxford; Colin; (Canvey Island, GB) ; Nichols;
Stephen; (Witham, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medivators Inc. |
Minneapollis |
MN |
US |
|
|
Family ID: |
1000006459124 |
Appl. No.: |
17/618989 |
Filed: |
June 8, 2020 |
PCT Filed: |
June 8, 2020 |
PCT NO: |
PCT/US20/36635 |
371 Date: |
December 14, 2021 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62864076 |
Jun 20, 2019 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 50/33 20160201;
A61B 2050/006 20160201 |
International
Class: |
A61B 50/33 20060101
A61B050/33 |
Claims
1.-16. (canceled)
17. An endoscope tray comprising an interior for storage of an
endoscope, the interior having an upstanding element having a top
surface; a plurality of apertures disposed on at least a portion of
the top surface of the upstanding element to facilitate drainage of
fluids; a bottom surface also having the plurality of apertures
disposed thereon; a sidewall and a rim disposed about the interior
of the tray; and a lid comprising at least one valve and configured
to engage the rim.
18. (canceled)
19. The endoscope tray of claim 17, wherein the sidewall does not
have a plurality of apertures.
20. The endoscope tray of claim 17, wherein the rim includes a
plurality of apertures.
21. The endoscope tray of claim 17, wherein the endoscope tray is
configured to engage the lid to seal the endoscope tray closed.
22. (canceled)
23. The endoscope tray of claim 17, wherein the at least one valve
is an exhaust valve and a release valve.
24. The endoscope tray of claim 17, wherein the endoscope tray
comprises a liner configured to engage with the interior of the
endoscope tray.
25. The endoscope tray of claim 17, wherein the endoscope tray
comprises a cover configured to enclose or partially enclose the
endoscope tray.
26. The endoscope tray of claim 25, wherein the cover is in a sheet
or a bag configuration.
27. The endoscope tray of claim 25, wherein the cover engages and
partially encloses the endoscope tray with an elastic portion.
28. A system for storage of an endoscope, the system comprising a
tray comprising an interior for storage of the endoscope, the
interior having an upstanding element having a top surface; a
plurality of apertures disposed on at least a portion of the top
surface of the upstanding element to facilitate drainage of fluids;
a sidewall and a rim disposed about the interior of the tray; a lid
comprising at least one valve comprising an exhaust valve and a
release valve to seal the lid with the tray; the lid configured to
engage the rim; and a liner configured to engage the rim of the
tray.
29. The system of claim 28, wherein the interior comprises at least
two upstanding elements spaced apart from each other to provide
support for a flexible medical endoscope coiled between all or a
portion of the at least two upstanding elements.
30. The system of claim 28, wherein the sidewall does not have a
plurality of apertures.
31. The system of claim 28, wherein the rim includes a plurality of
apertures.
32. The system of claim 28, wherein the liner engages contours of
the interior and the rim of the tray.
33. The system of claim 28, wherein the liner is disposable and is
substantially impermeable to fluids.
34. (canceled)
35. The system of claim 28, wherein the lid comprises a non-return
valve to seal the lid with the tray.
36-46. (canceled)
47. A system for storage of an endoscope, the system comprising a
tray comprising an interior for storage of the endoscope, the
interior having an upstanding element having a top surface; a
plurality of apertures disposed on at least a portion of the top
surface of the upstanding element to facilitate drainage of fluids;
a sidewall and a rim disposed about the interior of the tray; a lid
comprising a non-return valve to seal the lid with the tray; the
lid configured to engage the rim; and a liner configured to engage
the rim of the tray.
48. The system of claim 47, wherein the interior comprises at least
two upstanding elements spaced apart from each other to provide
support for a flexible medical endoscope coiled between all or a
portion of the at least two upstanding elements.
49. The system of claim 47, wherein the sidewall does not have a
plurality of apertures.
50. The system of claim 47, wherein the rim includes a plurality of
apertures.
Description
PRIORITY CLAIM
[0001] This application claims priority to and the benefit of U.S.
Provisional application with Ser. No. 62/864,076, filed on Jun. 20,
2019, entitled ENDOSCOPE STORAGE TRAY HAVING APERTURES AND METHOD
OF USE, which is herein incorporated by reference in its
entirety.
BACKGROUND
[0002] Endoscopes are well-known in the art and are commonly used
for numerous medical procedures. After each use, an endoscope will
undergo reprocessing by cleaning, disinfection and/or sterilization
to reduce or prevent contaminants from settling onto the endoscope,
as well as to prevent the spread of disease, viruses, bacteria, and
illness.
[0003] Often times, an Automated Endoscope Re-processor (AER) is
used to dry the reprocessed endoscopes. However, endoscopes have
channels with small internal diameters. There may be residual
moisture within those channels, even after AER drying, that may
provide an environment in which micro-organisms can quickly
multiply and potentially be a source to transmit infection to a
patient when an endoscopy is performed on that patient.
[0004] After endoscope reprocessing, an endoscope is generally
disposed within a clean tray and a clean cover can be secured to
the perimeter of the tray. The tray can then be loaded into a cart.
The endoscope is then transported from a reprocessing room, where
it is dried, and then transported back to a procedure room.
[0005] Before the reprocessed endoscope is disposed within the
tray, if the tray has been previously used and has been
contaminated, it must be cleaned to prevent the tray from
contaminating the reprocessed endoscope. Trays can be cleaned in a
cart washer, where fluid, chemicals and/or heat are applied to the
tray in order to wash the tray. However, during tray washing, fluid
can accumulate in the tray, making it harder for the tray to dry.
If moisture remains in the tray after an endoscope is disposed in
the tray, the moisture can increase the likelihood of contaminants
developing in the tray and/or the endoscope. Also, depending on the
configuration of the tray, it may not be compatible with the cart
washer and must instead be cleaned manually. Further, when trays
are loaded into the cart washer, often, the trays do not securely
engage with the cart washer.
[0006] Thus, there is a need to develop a new tray, systems and
methods where apertures are disposed on at least a portion of a
tray to facilitate drainage of fluid that is captured within the
tray during washing. There is also a need to develop a tray and a
cart that are compatible with each other, and where the tray
maintains a secure engagement with the cart. It would also be
beneficial to provide a tray that can be used during the final
stages of endoscope reprocessing so that the endoscope can remain
in the tray after reprocessing and then transported and stored in
the same tray.
SUMMARY
[0007] New devices, systems and methods are provided to facilitate
drainage of fluids from an endoscope tray when the tray is washed
in a cart. The tray and the cart are also provided to store the
endoscopes after they are washed. In some embodiments, an endoscope
tray is provided. The tray comprises an interior for storage of an
endoscope. The interior has an upstanding element having a top
surface, and a plurality of apertures disposed on at least a
portion of the top surface of the upstanding element to facilitate
drainage of fluids.
[0008] In some embodiments, an endoscope tray is provided. The tray
comprises an interior for storage of an endoscope. The interior has
a bottom surface and a sidewall. The bottom surface has a plurality
of apertures disposed on at least a portion of the bottom surface
to facilitate drainage of fluids, and the sidewall extends about
the interior of the endoscope tray and has no apertures.
[0009] In some embodiments, an endoscope tray is provided. The tray
comprises an interior for storage of an endoscope having an
upstanding element having a top surface. A plurality of apertures
are disposed on at least a portion of the top surface of the
upstanding element to facilitate drainage of fluids. A sidewall and
a rim are disposed about the interior of the tray, and a lid is
configured to engage the rim.
[0010] In some embodiments, a system for storage of an endoscope is
provided. The system comprising a tray comprising an interior for
storage of the endoscope. The interior has an upstanding element
having a top surface. A plurality of apertures are disposed on at
least a portion of the top surface of the upstanding element to
facilitate drainage of fluids. A sidewall and a rim are disposed
about the interior of the tray. A lid is configured to engage the
rim, and a liner is configured to engage the rim of the tray.
[0011] In some embodiments, a system for storage of an endoscope is
provided. The system comprises an endoscope tray comprising an
interior for storage of the endoscope. The interior has a bottom
surface and a sidewall. The bottom surface has a plurality of
apertures disposed on at least a portion of the bottom surface to
facilitate drainage of fluids. The sidewall extends about the
interior of the tray and has no apertures. A cart comprising a
mating surface configured to mate with a corresponding mating
surface of the tray to removably hold the endoscope tray in the
cart.
[0012] In some embodiments, a method of using an endoscope storage
tray is provided. The method comprises placing an endoscope within
an endoscope tray, the endoscope tray comprising an interior for
storage of the endoscope, the interior having an upstanding element
having a top surface, and a plurality of apertures disposed on at
least a portion of the top surface of the upstanding element to
facilitate drainage of fluids.
[0013] Additional features and advantages of various embodiments
will be set forth in part in the description that follows, and in
part will be apparent from the description, or may be learned by
practice of various embodiments. The objectives and other
advantages of various embodiments will be realized and attained by
means of the elements and combinations particularly pointed out in
the description and appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] In part, other aspects, features, benefits and advantages of
the embodiments will be apparent with regard to the following
description, appended claims and accompanying drawings.
[0015] FIG. 1 illustrates a perspective view of an endoscope tray.
The tray comprises an interior for storage of an endoscope having
an upstanding element having a top surface, and a plurality of
apertures disposed on at least a portion of the top surface of the
upstanding element to facilitate drainage of fluids.
[0016] FIG. 2 illustrates a side view of the tray, shown in FIG.
1.
[0017] FIG. 3 illustrates a perspective view of the tray of FIG.
1.
[0018] FIG. 4 illustrates a perspective view of the tray.
[0019] FIG. 5 illustrates a top view of an embodiment of the tray
in FIG. 1. In this embodiment, the tray comprises an interior for
storage of the endoscope. The interior has a bottom surface and a
sidewall. The bottom surface has a plurality of apertures disposed
on at least a portion of the bottom surface to facilitate drainage
of fluids, and the sidewall extends about the interior of the
endoscope tray and has no apertures.
[0020] FIGS. 6 and 6A illustrate a perspective view of the tray of
FIG. 1 shown with an endoscope disposed in the interior of the
tray. A liner is engaged with the interior of the tray and a cover
engages with the tray to enclose the tray. A rigid lid is shown
adjacent to the tray and can also engage the tray.
[0021] FIGS. 7, 7A, 7B, 7C and 7D illustrate embodiments of a valve
that is attached to the lid of FIGS. 6 and 6A. The valve
facilitates the sealing of the lid to the tray.
[0022] FIG. 8 illustrates a bottom perspective view of the tray and
an embodiment of the cover of FIG. 6. In this embodiment, the cover
engages and partially encloses the tray with an elastic
portion.
[0023] FIG. 9 illustrates a side view of the tray and an embodiment
of the cover of FIG. 6. In this embodiment, the cover is in a bag
configuration.
[0024] FIG. 9A illustrates a top view of the cover of FIG. 9 in a
reversible configuration. In this configuration, the cover is shown
on its reversible green/clean side.
[0025] FIG. 9B illustrates a top view of the cover of FIG. 9A shown
on its reversible red/biohazard side.
[0026] FIG. 10 illustrates a perspective view of the tray of FIG. 1
and a mating surface in the form of a frame. The frame is a
component of a cart and is configured to mate with a corresponding
mating surface of the tray to removably hold the tray into the
cart.
[0027] FIG. 11 illustrates a perspective view of a system for
storage of an endoscope. The system comprises the tray and frame of
FIG. 10 and a cart.
[0028] FIG. 12 illustrates a side view of the system of FIG.
11.
[0029] FIG. 13 illustrates a perspective view of the tray of FIG. 1
and a mating surface in the form of a frame. The frame is a
component of a cart and is configured to mate with a corresponding
mating surface of the tray to removably hold the tray into the
cart.
[0030] FIG. 14 illustrates a perspective view of a system for
storage of an endoscope. The system comprises the tray and frame of
FIG. 13 and a cart.
[0031] FIG. 15 illustrates a side view of the system of FIG.
14.
[0032] FIG. 16 illustrates a perspective view of the tray of FIG. 1
and a mating surface in the form of a frame. The frame is a
component of a cart and is configured to mate with a corresponding
mating surface of the tray to removably hold the tray into the
cart.
[0033] FIG. 17 illustrates a perspective view of a system for
storage of an endoscope. The system comprises the tray and frame of
FIG. 16 and a cart.
[0034] FIG. 18 illustrates a side view of the system of FIG.
17.
[0035] FIG. 19 illustrates a perspective view of the tray of FIG. 1
and a mating surface in the form of a frame. The frame is a
component of a cart and is configured to mate with a corresponding
mating surface of the tray to removably hold the tray into the
cart.
[0036] FIG. 20 illustrates a perspective view of a system for
storage of an endoscope. The system comprises the tray and frame of
FIG. 19 and a cart.
[0037] FIG. 21 illustrates a side view of the system of FIG.
20.
[0038] FIG. 22 illustrates a side view of the system of FIG. 11,
where multiple trays are stacked vertically within the cart.
[0039] FIG. 23 illustrates a top view of a mating surface of the
cart of FIG. 11 in the form of a frame. The frame is a component of
the cart and is configured to mate with a corresponding mating
surface of the tray to removably hold the tray into the cart. A
pocket is defined in the frame and the tray is configured to nest
within the pocket as the pocket is configured to receive and hold
at least a portion of the exterior of the tray. In this embodiment,
a perimeter of the frame is larger than at least a portion of the
tray.
[0040] FIG. 24 illustrates a partial front view of the cart of FIG.
11 disposed in the frame of FIG. 23, and the tray of FIG. 1 is in a
nested configuration with the frame.
[0041] FIG. 25 illustrates a top partially phantom view of a mating
surface of the cart of FIG. 11 in the form of a frame engaged with
a tray of FIG. 1. The frame is a component of the cart and is
configured to mate with a corresponding mating surface of the tray
to removably hold the tray into the cart. A pocket is defined in
the tray and the tray is configured to nest within the pocket. In
this embodiment, the perimeter of the tray is larger than the
frame.
[0042] FIG. 26 illustrates a partial front view of the cart of FIG.
10 disposed with the frame of FIG. 25 and the tray of FIG. 1 is in
a nested configuration with the frame.
[0043] FIG. 27 illustrates a perspective view of a system for
storage of an endoscope. The system comprises the tray of FIG. 1
and a cart.
[0044] It is to be understood that the figures are not drawn to
scale. Further, the relation between objects in a figure may not be
to scale, and may in fact have a reverse relationship as to size.
The figures are intended to bring understanding and clarity to the
structure of each object shown, and thus, some features may be
exaggerated in order to illustrate a specific feature of a
structure.
DETAILED DESCRIPTION
[0045] For the purposes of this specification and appended claims,
unless otherwise indicated, all numbers expressing quantities of
ingredients, percentages or proportions of materials, reaction
conditions, and other numerical values used in the specification
and claims, are to be understood as being modified in all instances
by the term "about." Accordingly, unless indicated to the contrary,
the numerical parameters set forth in the following specification
and attached claims are approximations that may vary depending upon
the desired properties sought to be obtained by the present
invention. At the very least, and not as an attempt to limit the
application of the doctrine of equivalents to the scope of the
claims, each numerical parameter should at least be construed in
light of the number of reported significant digits and by applying
ordinary rounding techniques.
[0046] Notwithstanding the numerical ranges and parameters set
forth herein, the broad scope of the invention are approximations,
the numerical values set forth in the specific examples are
reported as precisely as possible. Any numerical value, however,
inherently contains certain errors necessarily resulting from the
standard deviation found in their respective testing measurements.
Moreover, all ranges disclosed herein are to be understood to
encompass any and all subranges subsumed therein. For example, a
range of "1 to 10" includes any and all subranges between (and
including) the minimum value of 1 and the maximum value of 10, that
is, any and all subranges having a minimum value of equal to or
greater than 1 and a maximum value of equal to or less than 10,
e.g., 5.5 to 10.
[0047] Reference will now be made in detail to certain embodiments
of the invention, examples of which are illustrated in the
accompanying drawings. While the invention will be described in
conjunction with the illustrated embodiments, it will be understood
that they are not intended to limit the invention to those
embodiments. On the contrary, the invention is intended to cover
all alternatives, modifications, and equivalents that may be
included within the invention as defined by the appended
claims.
[0048] It is noted that, as used in this specification and the
appended claims, the singular forms "a," "an," and "the," include
plural referents unless expressly and unequivocally limited to one
referent. Thus, for example, reference to "outlet" includes one,
two, three or more outlets.
[0049] We refer now to the drawings wherein depicted elements are
not necessarily shown to scale and wherein like or similar elements
are designated by the same reference numeral through the several
views.
[0050] Referring to the drawings in general, it will be understood
that the illustrations are for the purpose of describing particular
embodiments of the disclosure and are not intended to be limiting
thereto.
[0051] While most of the terms used herein will be recognizable to
those of ordinary skill in the art, it should be understood that
when not explicitly defined, terms should be interpreted as
adopting a meaning presently accepted by those of ordinary skill in
the art.
[0052] In some embodiments, a tray is provided that is cart washer
compatible and that is chemical and heat resistant. In some
embodiments, the tray is configured for engagement with cart washer
compatible trays and lids. The tray is designed to minimize pooling
of fluid within the tray to facilitate drying during a final phase
of a reprocessing cycle. In some embodiments, the tray is contoured
to allow an endoscope to be retained more securely within an
interior of the tray than if the endoscope was retained in a
standard tray, thereby minimizing components of the endoscope from
being damaged. For example, a light guide connector of the
endoscope is heavy and can cause impact damage if it comes into
contact with a patient insertion tube of a distal end of an
endoscope.
[0053] In some embodiments, dimensions of the tray can be
sufficient to accommodate substantially all sizes of flexible
medical endoscopes in a coiled state without undue stress being
applied to the flexible portions of the endoscope. However, the
tray can also be sufficiently small to permit it to be easily
carried by a person. In some embodiments, the tray is constructed
and dimensioned to provide support for the endoscope coiled in a
stress-free state.
[0054] In some embodiments, the tray is rigid and re-usable and
comprises a base having planar and non-planar portions and
surrounding sidewalls upstanding therefrom, the tray being formed
of a semi-rigid material capable of withstanding repeated
disinfection and dimensioned to provide support for a flexible
medical endoscope coiled in a stress-free state.
[0055] In some embodiments, a shaped tray is provided that is cart
washer compatible, has apertures (e.g., perforations) to allow
improved automated cleaning, prevents pooling of a fluid in an
interior of the tray and improves drying at the end of a cart
washer cycle. In some embodiments, the tray is designed to prevent
contact of sensitive areas of an endoscope from coming into contact
with each other during storage and transportation which prevents
damage to the endoscope.
[0056] In some embodiments, a lid is provided that engages with the
tray and is also cart washer compatible. In some embodiments, the
lid does not include apertures. In some embodiments, the lid is
self-sealing on an upper surface of the tray. The lid can seal onto
the tray by the natural vacuum created when the lid and tray mate.
In some embodiments, the lid includes one or more valves, such as
an exhaust valve to allow displacement of trapped air, and a
release valve to allow pressure to equalize so that the lid can be
removed from the tray.
[0057] In some embodiments, a shaped base liner is provided
configured to engage with an interior of the tray. In some
embodiments, the liner contours the interior of the tray and
creates a contact engagement. In some embodiments, the tray can
engage with a mating surface of a cart to support the tray and
secure it to a cart during transportation. In some embodiments, the
tray improves storage and transport decontamination.
Tray
[0058] Referring to FIGS. 1-6A, an endoscope tray 20 is provided.
The tray is configured to store a flexible medical endoscope 22 and
to facilitate drainage of fluids that are captured within the tray
during tray washing. In some embodiments, the tray is rigid and
reusable. In some embodiments, the tray can be formed of a
semi-rigid material capable of withstanding repeated disinfection
and dimensioned to provide support for the endoscope coiled in a
stress-free state.
[0059] The tray comprises an interior 24 for storage of the
endoscope. The interior defines an inner surface 26 that forms a
base or bottom surface 27 that includes an upstanding element 28.
The upstanding element is configured to embrace and protect coils
30 of the endoscope without undue stress being applied to the
endoscope when stored in the tray. In some embodiments, the
interior comprises at least two upstanding elements spaced apart
from each other to provide contour and support to at least a
portion of the endoscope coiled between all or a portion of the at
least two upstanding elements, as shown in FIG. 4.
[0060] The interior can define more than one or two upstanding
elements. For example, the interior can define 3, 4, 5 or 6
upstanding elements. In some embodiments, at least a portion of the
upstanding element can include a curved portion or a side wall 34
and a straight portion or a side wall 36. In some embodiments, each
of the side walls of the upstanding element/elements have no
apertures.
[0061] The upstanding element includes a top surface 38. The top
surface includes a plurality of apertures 40 disposed on at least a
portion of the top surface of the upstanding element to facilitate
drainage of fluids. The apertures can be variously configured and
can be circular holes, indents, slits, and/or cutout shapes. In
some embodiments, the apertures can be in discrete positions on the
top surface, on edges of the top surface, or can be randomly
positioned on the top surface.
[0062] The top surface can include from 1 to about 1000, from 1 to
about 500, from 1 to about 250, from 1 to about 100, from 1 to
about 75, from 1 to about 50, from 1 to about 25, from 1 to about
20, from 1 to about 15, from 1 to about 10, or from 1 to about 5
apertures on the top surface of the upstanding element. In some
embodiments, the top surface can include from about 1, 2, 3, 4, 5,
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,
24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40,
41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 75, 100, 125, 150, 175,
200, 225, 250, 275, 300, 325, 350, 375, 400, 425, 450, 475, 500,
525, 550, 575, 600, 625, 650, 675, 700, 725, 750, 775, 800, 825,
850, 875, 900, 925, 950, 975 to about 1000 apertures on the top
surface. The apertures are positioned to allow air flow into the
tray, as shown in FIG. 2, and allow drainage of fluid and/or
moisture from the reprocessed endoscope to be removed from the
tray. This is also for trays that are stored in rows and/or are
stacked in a cart.
[0063] The apertures can have a certain size. For example, the
apertures can be from about 1 millimeter (mm) to about 10 mm, from
about 1 mm to about 8 mm, from about 1 mm to about 6 mm, from about
1 mm to about 4 mm, and/or from about 1 mm to about 2 mm. In some
embodiments, the apertures can be the same size or different sizes.
The apertures can be a certain shape, such as, for example,
circular, oval, disc, star, rectangular, square, triangular,
freeform, semicircular, octagonal, pentagonal, cross, ring,
crescent, hexagonal and/or quatrefoil shaped. In some embodiments,
the apertures can be the same or different shapes.
[0064] The base or bottom surface of the tray, as described above,
can include a plurality of apertures disposed thereon. As shown in
FIGS. 3 and 4, the apertures can be sealed apertures 42. In some
embodiments, the sealed apertures can be punctured manually if a
user wishes to drain a tray more quickly.
[0065] The base or bottom surface of the tray can include
surrounding sidewalls 44 upstanding therefrom. The sidewalls extend
about the interior and have no apertures. In some embodiments, the
sidewalls are continuous and are monolithic with the base or bottom
surface of the tray. In some embodiments, the base or bottom
surface includes planar portions 46 and non-planar portions such as
the upstanding elements, as described above and shown in FIG. 1.
The tray can also include non-planar portions 47 on a portion of
the exterior sidewalls or exterior on the base of the tray, as
shown in FIG. 6.
[0066] The tray can include a rim 48. In some embodiments, the rim
includes the plurality of apertures, and the top surface of the at
least two upstanding elements align with the rim on a same plane.
As shown in FIG. 2, the tray can also include a peripheral lip 50
disposed at least partially around the surrounding sidewalls and
extending outwardly therefrom. The tray includes a bottom 52, as
shown in FIG. 3. In some embodiments, the bottom of the tray is
configured to engage with at least a portion of a cover, as
described herein.
[0067] As shown in FIG. 5, the tray alternatively does not include
an upstanding element, and the plurality of apertures are disposed
on at least a portion of the bottom surface to facilitate drainage
of fluids. In some embodiments, the bottom surface of the tray
and/or the rim can include the plurality of apertures.
[0068] It will be understood that in some embodiments, the all
apertures extend completely through the tray to maximize drainage
and air flow. In some embodiments, some of the apertures do not
extend completely through the tray and there may be a mix of
apertures extending completely through and those that do not extend
completely through the tray.
[0069] The tray can be made from a material such as, for example, a
polymeric material. The polymeric material can be thermoplastic
and/or is a polycarbonate. For example, the tray can be fabricated
from materials such as machined or injection molded thermoplastics
such as polyaryletherketone (PAEK) including polyetheretherketone
(PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK),
carbon-PEEK composites, PEEK-BaSO4 polymeric rubbers, polyethylene
terephthalate (PET), fabric, silicone, polyurethane,
silicone-polyurethane copolymers, polymeric rubbers, polyolefin
rubbers, semi-rigid and rigid materials, elastomers, rubbers,
thermoplastic elastomers, thermoset elastomers, elastomeric
composites, polyphenylene, polychloropene, polyamide,
polyetherimide, polyethylene, epoxy, partially resorbable
materials, totally resorbable materials, polyglycolide,
polytyrosine carbonate, polycaprolactone, silicone based rubber,
liquid silicone rubber, High Consistency Rubber, silicon, TPE,
Polypropylene, Polycarbonate, ABS or any combination thereof. The
tray can also be made from steel, aluminum, paper, bamboo, cork,
glass, hemp or any combination thereof.
[0070] In some embodiments, the tray can have a certain length,
width and height. In some embodiments, the length of the tray can
be from about 16 to about 34 inches, the width can be from about 12
to about 24 inches and the height can be from about 3 to about 8
inches. In some embodiments, the length of the tray can be from
about 16, 18, 20, 22, 24, 26, 28, 30, 32 to about 34 inches, the
width of the tray can be from about 12, 14, 16, 18, 20, 22 to about
24 inches, and the height of the tray can be from about 3, 4, 5, 6,
7 to about 8 inches.
[0071] The components of the tray, individually or collectively,
may also be fabricated from a heterogeneous material such as a
combination of two or more of the above-described materials. The
tray as described herein may be constructed of a suitable
biocompatible material to impart various desirable characteristics,
such as rigidity, and resilience.
[0072] Components of the tray can also be made from a suitable
material such as for example, polyurethane, polyurea,
polyether(amide), PEBA, thermoplastic elastomeric olefin,
copolyester, styrenic thermoplastic elastomer, carbon fiber, glass
fiber, ceramics, methacrylates, poly (N-isopropylacrylamide),
plastic (e.g., polycarbonates), ABS, MABS, or the like or
combinations thereof.
Storage System
[0073] Referring to FIGS. 6-27, an endoscope storage system 53 is
provided. The system comprises tray 20, as described above. In some
embodiments, the system comprises a rigid lid 54 configured to
engage with the rim of the tray to seal the tray closed, as shown
in FIGS. 6 and 6A. In some embodiments, the lid can self-seal with
the rim of the tray by a natural vacuum created when the lid is
mated with the tray. In some embodiments, the lid comprises at
least one valve 56 to facilitate sealing the tray closed. In some
embodiments, the at least one valve can have similar features to
the one-way valve found and described in U.S. Publication No.
2015/0259122, assigned to Cantel (UK) Limited. This publication is
herein incorporated by reference.
[0074] In some embodiments, the at least one valve is an exhaust
valve and a release valve to seal the lid with the tray, as shown
in FIG. 6. In some embodiments, the at least one valve is a
non-return valve/one-way valve, as shown in FIGS. 7 to 7D. When the
lid is engaged with the tray, the at least one valve communicates
with airspace within the interior of the tray.
[0075] In some embodiments, the at least one valve includes a valve
that allows fluid (liquid or gas) to flow through it in only one
direction thereby preventing any backward flow. Conventional
one-way valves can be used that are provided in the lid that allow
fluid (liquid or gas) to flow through it in only one direction
thereby preventing any backward flow. The one-way valve can be
controlled by the pressure applied to the valve and will open when
the pressure inside and the pressure outside of the valve are
different. This can be placed on after the moisture or fluid is
removed by the apertures.
[0076] In some embodiments, the at least one valve comprises an
outlet 58 configured to release air flowing from the interior of
the tray, an inlet 60 to allow air from the interior to enter the
at least one valve when suction is applied, and a seal 62 that
allows only air to enter the inlet for release out of the outlet,
as shown in FIG. 7. The seal is disposed between the inlet and the
outlet and is a movable barrier configured to reduce or prevent
contaminants from entering into the interior of the tray.
[0077] In some embodiments, the at least one valve can be a
pressure valve or a degassing valve, as shown in FIG. 7, a duckbill
valve, as shown in FIG. 7A, a flap valve, as shown in FIG. 7B, a
valve comprising a single slit diaphragm, as shown in FIG. 7C or a
valve comprising a double or cross shaped slit diaphragm, as shown
in FIG. 7D.
[0078] In some embodiments, the at least one valve is a controlling
device for the passage of suction in one direction and is
controlled by the suction applied to the at least one valve by a
suction device (not shown), such as a vacuum. For example, the at
least one valve will be closed when no suction is provided,
however, when suction is provided, the suction will force the at
least one valve to open, thereby releasing air from the interior of
the tray. It is to be understood that the at least one valve is a
valve that allows the passage of air in one direction and that the
at least one valve will open when the pressure or suction outside
of the interior is less than the pressure inside of the interior.
The at least one valve will close when pressure difference between
the outside of the tray and the interior is not significantly
different. The pressure difference, in some embodiments, will aid
in removing moisture or fluid from the endoscope.
[0079] In some embodiments, the at least one valve can be
positioned within or on the lid in a few ways. For example, the at
least one valve can be centrally attached to the lid or it can be
attached to an edge of the lid. In some embodiments, the at least
one valve is monolithically formed with the lid or is attached to
the lid by an adhesive, a friction fitting and/or tape.
[0080] In some embodiments, the system includes a liner 64. The
liner is configured to engage with the interior of the tray and the
endoscope, as shown in FIG. 6. In some embodiments, the liner
engages contours of the interior and rim of the tray. In some
embodiments, the liner is similar to the liner found and described
in U.S. Pat. No. 6,749,063, assigned to Cantel (UK) Limited. This
patent herein is incorporated by reference. The liner can be
disposable and can be substantially impermeable to fluids.
[0081] In some embodiments, the tray interior and portions of the
exterior of the tray can be engaged by the liner. The liner can be
made of a flexibly deformable material substantially impermeable to
fluids.
[0082] In some embodiments, the disposable liner contacts the
bottom surface of the tray and at least partially encloses the
reprocessed endoscope. In some embodiments, the liner is a
disposable single use liner that may be sterile or unsterile.
[0083] In some embodiments, the disposable liner is configured to
temporarily line the entirety of the interior compartment of the
tray and prevents the endoscope from having direct contact with the
interior of the tray. In some embodiments, the liner prevents
moisture from the reprocessed endoscope from contacting the tray
and when the tray is used repeatedly, it prevents or reduces
contamination from one endoscope to the next endoscope.
[0084] The tray whether it is lined or not lined can be temporarily
covered with a disposable cover 66, as shown in FIGS. 6, 8 and
9-9B. In some embodiments, the disposable cover at least partially
encloses or encloses the reprocessed endoscope and the tray. In
some embodiments, the cover is a disposable single use cover that
may be sterile or unsterile. In some embodiments, the cover can be
similar to the cover found and described in U.S. Pat. No.
6,749,063, assigned to Cantel (UK) Limited. This patent is herein
incorporated by reference.
[0085] The cover for the endoscope storage tray can comprise a
flexibly deformable sheet material substantially impermeable to
fluids, the flexibly deformable sheet material configured to be
temporarily secured to the endoscope storage tray so as to cover at
least an interior of the endoscope storage tray. The cover can
engage with the rim and/or the lip of the tray to temporarily
secure the cover to the tray.
[0086] In some embodiments, the cover can be in a sheet (FIGS. 6
and 8) or a bag/pouch configuration (FIGS. 9-9B). For example, when
the cover is in a bag/pouch configuration, the cover can be a
reversible pouch, as shown in FIGS. 9A and 9B. The reversable
bag/pouch is configured to entirely enclose the tray. In some
embodiments, the reversible bag/pouch can have a clean/green
colored side 63 and a biohazard/red side 65. The clean/green side
can have indicia 67 in the form of a word, words and/or symbols.
For example, the indicia can be the word "CLEAN". In some
embodiments, the biohazard/red side can have indicia 115 in the
form of a word, words and/or symbols. For example, the indicia can
be the word "BIOHAZARD". When the tray is inserted/engaged into a
cart, as described below, and the clean/green side is facing
upward, this can indicate to a user that the endoscope is clean and
ready for use. When the tray is inserted/engaged into the cart and
the biohazard/red side is facing upward, this can indicate to a
user that the endoscope is contaminated, should not be used and
that the endoscope needs to be reprocessed. In some embodiments,
the reversible bag/pouch can have a clear/transparent viewing
window 69 in the center of each side of the bag/pouch. In some
embodiments, the reversible bag/pouch can be sealed by a
zipper.
[0087] In some embodiments, the cover engages and partially
encloses the tray with an elastic portion 68, as shown in FIG. 8.
In some embodiments, the sheet or bag configuration can have a
rectangular shape to correspond with the shape of the tray but
other cover shapes are contemplated depending on tray shape. These
shapes include oval, square, circular or the like. In some
embodiments, the cover can be temporarily secured to the rim of the
tray, and/or the bottom of the tray.
[0088] The cover can be manufactured in different colors such as in
a green or a clear color to indicate that the endoscope is clean
and ready for use. A red color, in some embodiments, could indicate
that the tray should not be used and the endoscope should be
cleaned. Alternative colors can be selected such as blue, pink,
yellow, orange, brown or black to indicate the status of the
endoscope. In some embodiments, the cover can be reversible and a
different color can be used on the inner surface than on the outer
surface of the cover.
[0089] The system includes a cart 70, as shown in FIGS. 10-26. The
cart is configured to assist in the transportation and/or storage
of one or more of the trays that store one or more endoscopes. It
is to be understood that the cart is defined as a mobile storage
unit. However, a cabinet which is defined as a static or stationary
storage unit can alternatively be used. The cart can also be an
endoscope washing and/or drying cart. The cart includes a housing
72. The housing includes a first side panel 74 and a second side
panel 76, as shown in FIG. 11. The first and the second side panels
are in a parallel configuration relative to each other and are
spaced apart at a certain distance, such as, for example, a
distance that is greater than the width of the trays. Each of the
side panels include a first support 78, a second support 80, a rail
82 and a base 84. The first and the second support are in a
parallel configuration relative to each other and the rail and the
base are in a parallel configuration relative to each other.
[0090] The rail extends from a first end 86 to a second end 88. The
first end fixedly engages with the first support by an engagement
means 90, such as a bracket, screw, adhesive and/or soldering. In
some embodiments, the first end and the first support are
manufactured fused together and are monolithic. The first end and
the first support, in some embodiments, form a 45-degree angle
where they engage. The second end fixedly engages with the second
support by engagement means 90. In some embodiments, the second end
and the second support are manufactured fused together and are
monolithic. The second end and the second support form a 45-degree
angle where they engage. The base extends between a proximal end 92
and a distal end 94, and includes an upper surface 96 and a lower
surface 98. The base fixedly engages with an end 100 of the first
support at the upper surface and toward the proximal end. The base
and the end of the first support can form a 45-degree angle where
they engage. The base fixedly engages with an end 102 of the second
support at the upper surface and toward the distal end. The base
and the end of the second support can form a 45-degree angle where
they engage. The base and end 100 of the first support and end 102
of the second support can fixedly engage via engagement means,
similar to those described above with regard to engagement means
90. A first brace 101 and a second brace 103 fixedly engage the
bases.
[0091] In some embodiments, each rail of each of the side panels
collectively form a runner assembly 104. The runner assembly is
configured for engaging with the tray and allows for the movement
of the tray in a forward and backward direction once removably
mounted on the runner assembly. Each rail includes an inner side
106 that includes a slot 108. A bearing 110 can be positioned
within the slot to facilitate retractable movement of an arm 112.
In some embodiments, the bearing and the arm movably engage
relative to each other.
[0092] As shown in FIG. 10, the cart includes a mating surface,
such as a frame 114. The frame can be variously configured, as
shown in FIGS. 10, 13, 16 and 19. The frame is configured to mate
with a corresponding mating surface 116 of the tray (FIG. 10) to
removably hold the endoscope tray in the cart. The tray removably
engages the frame, and the cart allows the tray containing the
endoscope to be transported to a patient for use. In some
embodiments, the mating surface of the tray corresponds to a
particular frame (e.g., mating surface) of the cart and the frame
(e.g., mating surface) of the cart corresponds to a particular
mating surface of the tray.
[0093] In some embodiments, the mating surface of the tray can be
at least a portion of the sidewalls of the tray, the peripheral lip
and/or the rim of the tray. The mating surface of the tray and the
frame (e.g., mating surface) of the cart can also temporarily lock.
For example, the mating surface of the tray can include one or more
recesses 118 that mates with one or more projections 120 on the
frame, as shown in FIGS. 10, 13 and 16. Alternatively, the mating
surface of the tray can include one or more projections 122 that
mates with one or more recesses 124 on the frame, as shown in FIG.
19. In some embodiments, the tray and the frame can be in locked
engagement through one or more grooves, teeth, indents, tongues,
peaks, valleys, ribs, flanges, dimples, slots, or a combination
thereof disposed on the mating surface of the tray and the frame.
The locked engagement can include, but is not limited to a friction
fit, pressure it, or male/female engagement.
[0094] The frame can be fixedly or removably engaged with the
runner assembly. In some embodiments, the frame can be variously
configured. For example, the frame can be in a basket configuration
as shown in FIGS. 10-12, where the mating surface of the tray is
the peripheral lip and side wall; a solid mount with bracketed
edges configuration as shown in FIGS. 13-15, where the mating
surface of the tray are portions of the peripheral lip and the tray
has a locked engagement with the frame projections; a railed
configuration as shown in FIGS. 16-18, where the mating surface of
the tray are portions of the peripheral lip and the tray has a
locked engagement with the rail projections; and a low profile
solid mount as shown in FIGS. 19-21 where the mating surface of the
tray are the sidewalls and the peripheral lip.
[0095] The cart can be configured to utilize all of the frames of
FIGS. 10-21 in a single cart. In some embodiments, one or all of
the frame embodiments can be in a stacked configuration within the
cart, as shown in FIG. 22. One or more trays can also be stacked in
the cart and disposed with lids, covers and/or liners.
[0096] The frames can include pockets 126 that are configured for
portions of the tray to nest within. The perimeter of the tray, in
some embodiments, is smaller than the perimeter of the frame so
that the tray nests within the frame, as shown in FIGS. 23 and 24.
When the perimeter of the tray is smaller than the perimeter of the
frame, there is no tray rim or lip overhang. The perimeter of the
tray, in some embodiments, is larger than the perimeter of the
frame so that the tray nests within the frame, as shown in FIGS. 25
and 26. When the perimeter of the tray is larger than the perimeter
of the frame, the rim or lip of the tray will overhang relative to
the frame.
[0097] The system can alternatively include a cart 128, as shown in
FIG. 27. The cart is configured for storage and/or transportation
of the trays. The cart comprises a housing 130. The housing
includes opposing side walls 132, 134 and top and bottom walls 136,
138. The cart can be in a rectangular configuration. An interior
140 of the housing comprises one or a plurality of slots 142, each
configured to slidably receive the tray. The slots are transverse
relative to the opposing side walls. Each slot is defined by ledges
144, 146 that are in parallel orientation relative to each other.
The cart can comprise one or more slots, such as 1 to about 12
slots.
[0098] In some embodiments, the bottom wall includes an exterior
surface 148 that attaches to a plurality of wheels 150, such as
caster wheels. The cart can include 4 or more wheels disposed at
corners of the exterior surface. The cart can be washed and can be
heat and chemical resistant.
[0099] The tray can be configured to nest in a specific row in the
cart. In this way, a tray cannot be used in a different cart or a
different row in the cart. Therefore, a tray that does not have
apertures on the bottom surface of the tray, on at least a portion
of the top surface of one or more of the upstanding elements,
and/or on the rim of the tray would not be able to be used in that
cart. Further, specific trays and specific carts can be tailored
for specific endoscope suites in a medical facility and can be
tailored for patient specific use.
[0100] It is to be understood that the tray engaged with the lid,
liner and/or the cover and disposed with the cart for storage
and/or transportation can reduce the number of receptacles used for
endoscope reprocessing and delivery.
[0101] The cart can be made from various materials, including, but
not limited to metals, such as for example, stainless steel alloys,
commercially pure titanium, titanium alloys, Grade 5 titanium,
cobalt-chrome alloys, or combinations thereof. In some embodiments,
the cart can be made from thermoplastic materials and/or the
materials described above with regard to the tray. In some
embodiments, the cart are configured to be heat and chemical
resistant.
[0102] In some embodiments, contaminants can include, but are not
limited to, biological contaminants such as microorganisms
including bacteria, viruses, yeasts, molds and parasites; air borne
contaminants such as airborne microbes; and/or chemical
contaminants. In some embodiments, bacterial can include, but is
not limited to Escherichia coli, Klebsiella species, Enterobacter
species, enterococci, Pseudomonas aeruginosa and Salmonella
species.
Methods and Kits
[0103] A method of using an endoscope storage tray is provided. The
method comprises placing an endoscope within an endoscope tray, the
endoscope tray comprising an interior for storage of the endoscope,
the interior having an upstanding element having a top surface, and
a plurality of apertures disposed on at least a portion of the top
surface of the upstanding element to facilitate drainage of fluids.
It is to be understood that the tray is tray 20 described above
with regard to FIGS. 1-6A.
[0104] In some embodiments, the interior comprises at least two
upstanding elements spaced apart from each other to provide support
for a flexible medical endoscope coiled between all or a portion of
the at least two upstanding elements. In some embodiments, the
upstanding elements contour portions of the endoscope. In some
embodiments, a rigid lid engages the tray. In some embodiments, a
disposable liner engages with the interior of the tray.
[0105] In some embodiments, components of the system described
above may be made by injection molding, compression molding, blow
molding, thermoforming, die pressing, slip casting, electrochemical
machining, laser cutting, water-jet machining, electrophoretic
deposition, powder injection molding, sand casting, shell mold
casting, plaster-mold casting, investment casting, vacuum casting,
permanent-mold casting, slush casting, pressure casting, die
casting, centrifugal casting, squeeze casting, rolling, forging,
swaging, extrusion, shearing, spinning, or combinations
thereof.
[0106] In some embodiments, the components of the system may be
formed by 3D printing. The terms "three-dimensional printing
system," "three-dimensional printer," and "printing," describe
various solid freeform fabrication techniques for making
three-dimensional articles or objects by selective deposition,
jetting, fused deposition modeling, multi-jet modeling, and other
additive manufacturing techniques now known in the art or that may
be known in the future that use a build material or ink to
fabricate three-dimensional objects.
[0107] Instructions in the form of schematics encompassing any of
the embodiments disclosed herein may be given to a computer to be
carried out by a 3D printer. In some embodiments, components of the
system may be color coded to signify various properties.
[0108] Components of the system may be sterilizable. In various
embodiments, one or more components of the system are sterilized by
radiation in a terminal sterilization step in the final packaging.
Terminal sterilization of a product provides greater assurance of
sterility than from processes such as an aseptic process, which
require individual product components to be sterilized separately
and the final package assembled in a sterile environment.
[0109] Typically, in various embodiments, gamma radiation is used
in the terminal sterilization step, which involves utilizing
ionizing energy from gamma rays that penetrates deeply in the
device. Gamma rays are highly effective in killing microorganisms,
they leave no residues nor have sufficient energy to impart
radioactivity to the device. Gamma rays can be employed when the
device is in the package and gamma sterilization does not require
high pressures or vacuum conditions, thus, package seals and other
components are not stressed. In addition, gamma radiation
eliminates the need for permeable packaging materials.
[0110] In various embodiments, electron beam (e-beam) radiation may
be used to sterilize one or more components of the system. E-beam
radiation comprises a form of ionizing energy, which is generally
characterized by low penetration and high-dose rates. E-beam
irradiation is similar to gamma processing in that it alters
various chemical and molecular bonds on contact, including the
reproductive cells of microorganisms. Beams produced for e-beam
sterilization are concentrated, highly-charged streams of electrons
generated by the acceleration and conversion of electricity.
[0111] Other methods may also be used to sterilize one or more
components of the system, including, but not limited to, gas
sterilization, such as, for example, with ethylene oxide or steam
sterilization.
[0112] In various embodiments, a kit or system is provided that may
include additional parts along with the tray combined together to
be used with the cart. The kit may include the tray in a first
compartment. A second compartment may include the cover. A third
compartment may include the liner. A fourth compartment may include
the lid. A fifth compartment may include cleaning solutions, gloves
and other procedural supplies for performing cleaning of the
endoscope, as well as an instruction booklet or notification of a
website where instructions for using the kit or system can be
located. Each component of the system or kit may be separately
packaged in a plastic pouch. A cover of the kit may include
illustrations of the use of the cover and a clear plastic cover may
be placed over the compartments to maintain sterility.
[0113] From the foregoing description, one of ordinary skill in the
art can easily ascertain the essential characteristics of this
disclosure, and without departing from the spirit and scope
thereof, can make various changes and modifications to adapt the
disclosure to various usages and conditions. The implementations
described hereinabove are meant to be illustrative only and should
not be taken as limiting of the scope of the disclosure, which is
defined in the following claims.
* * * * *